Effect of Prebiotic Intake on Adiposity, Satiety and Gut Microbiota in Overweight and Obese Children

Obesity Clinical Trial

Official title:

Effect of Prebiotic Intake on Adiposity, Satiety and Gut Microbiota in Overweight and Obese Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02125955
• Other study ID #: UC-1026386
• Status: Completed
• Phase: N/A
• First received: April 25, 2014
• Last updated: October 24, 2017
• Start date: February 2014
• Est. completion date: September 2017

Study information

• Verified date: October 2017
• Source: University of Calgary
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Currently, over one third of Canadian children and youth aged five to seventeen are overweight or obese. Childhood obesity leads to increased risks of co-morbidities such as type 2 diabetes, fatty liver disease, cardiovascular disease and certain types of cancers. Changes in the food supply have been linked to obesity and include a decrease in the intake of dietary fiber. Prebiotic fibers are a group of non-digestible carbohydrates that modulate the composition and actions of the gut microbiota and have been shown to reduce body fat and energy intake in overweight and obese adults. The investigators hypothesis is that prebiotic fiber intake in overweight and obese children will similarly result in improvements in body composition and reduced energy intake.

Description:

Obesity in the pediatric population is a primary public health concern given that overweight and obesity in childhood continues into adulthood. Consumption of high-fat, calorie-dense diets do not provide individuals with the suggested daily intake of many important nutrients. This is especially true for dietary fiber which has positive health benefits such as roles in weight management. A form of dietary fiber with links to obesity treatment/prevention is prebiotic fiber. In the gut, there are many bacteria which have been shown to affect a person's health depending on the type and number of each type of bacteria. The role of prebiotic fiber is to increase the number of beneficial bacteria which in turn promotes health. Studies in humans have shown that prebiotic fiber is effective at reducing body fat and food intake in overweight and obese adults. The aim of this study is to see if prebiotic fiber can provide the same benefits to overweight and obese children. Since weight management becomes increasingly difficult as a person ages, treatments that promote weight maintenance at an early age are critically needed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: September 2017
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 12 Years

Eligibility

Inclusion Criteria:

• Boys and girls between the ages of 7-12 years old

• BMI percentiles >85th percentile for their age and sex

• Tanner stage of = 3, girls premenarche

Exclusion Criteria:

• Tanner stage of >3 or girls postmenarchal

• Use of antibiotics up to 3 months prior to study

• Regular prebiotic supplement and/or probiotic supplement use

• Subjects unable to provide consent (parental) or assent (child)

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Dietary Supplement:
• Prebiotic fiber
Dissolved in water.
• Placebo
Dissolved in water

Locations

Country	Name	City	State
Canada	University of Calgary	Calgary	Alberta

Sponsors (2)

Lead Sponsor	Collaborator
University of Calgary	Alberta Children's Hospital

Country where clinical trial is conducted

Canada, 

References & Publications (2)

Hume MP, Nicolucci AC, Reimer RA. Prebiotic supplementation improves appetite control in children with overweight and obesity: a randomized controlled trial. Am J Clin Nutr. 2017 Apr;105(4):790-799. doi: 10.3945/ajcn.116.140947. Epub 2017 Feb 22. — View Citation

Nicolucci AC, Hume MP, Martínez I, Mayengbam S, Walter J, Reimer RA. Prebiotics Reduce Body Fat and Alter Intestinal Microbiota in Children Who Are Overweight or With Obesity. Gastroenterology. 2017 Sep;153(3):711-722. doi: 10.1053/j.gastro.2017.05.055. E — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Gut microbiota	Change in baseline gut microbiota at 16 weeks.	16 weeks
Other	Serum lipids	Change in baseline serum lipids at 16 weeks.	16 weeks
Other	Serum glucose and insulin	Change in baseline glucose and insulin at 16 weeks.	16 weeks
Other	Inflammatory markers	Change in serum inflammatory markers at 16 weeks.	16 weeks
Primary	Body fat	Change in baseline fat mass at 16 weeks. Measured by dual energy x-ray absorptiometry.	16 weeks
Secondary	Appetite regulation	Change in baseline appetite at 16 weeks. Subjective appetite assessed with visual analog scales and eating behavior questionnaire. Objective measures include a weighed breakfast buffet, weighted 3-day food records and serum satiety hormone levels.	16 weeks